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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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9 January 2017 |
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Main ID: |
NCT02998112 |
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Date of registration:
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13/12/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Fecal Microbiota Transplantation for Ulcerative Colitis Through Colonic Transendoscopic Enteral Tubing
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Scientific title:
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Date of first enrolment:
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December 2016 |
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Target sample size:
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188 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02998112 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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China
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Contacts
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Name:
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Faming Zhang, MD, PhD |
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Address:
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Telephone:
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086-25-58509883 |
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Email:
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fzhang@njmu.edu.cn |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Active, moderate to severe severity (Mayo score more than 6)
- Safety using history of 5-ASA.
- Able to undergo endoscopy examination.
Exclusion Criteria:
- Immunosuppressive drugs and glucocorticoids using in 4 weeks
- Antibiotic using in 7 days
- High risk of toxic megacolon
- Colon cancer or neoplasia in pathophysiology
- Other severe diseases (eg: cardiovascular, respiratory, gastroenteral and kidney
diseases)
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
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Intervention(s)
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Drug: fecal microbiota transplantation
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Drug: Saline
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Primary Outcome(s)
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Clinical improvement
[Time Frame: 12 weeks]
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Clinical remission
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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Intestinal microbiota changing
[Time Frame: 12 weeks]
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Secondary ID(s)
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FMT-UC-121101
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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